Tiêu chuẩn iso 14243 2 2016

© ISO 2016 Implants for surgery — Wear of total knee joint prostheses — Part 2 Methods of measurement Implants chirurgicaux — Usure des prothèses totales de l’articulation du genou — Partie 2 Méthodes[.]

Implants for sur g ery — Wear oftotal

Part 2:

Impla t chirurgica x — Usur des prothè se s totale s de l’articulation

du gen u —

Partie 2: Méth de s de me sur

T ir d edition

2 16-0 -0

Reference n mb r

ISO 14243-2:2 16(E)

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms an definitions 1

4 Gravimetr ic metho 1

4.1 Principle 1

4.2 Reag ent an mate ials 1

4.3 A pp r atus 2

4.4 Tes an contr ol spe imens 2

4.5 Pr eparation of tes an contr ol spe imens for g ra vimetric measurement (pre-so k con itioning ) 2

4.6 Pr oc dure for g ra vimetric measurement .3

5 Test rep r t 3

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desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sp nsible for identifying any or al such p t ent right Detais of

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F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for this document is ISO/TC 1 0, Impla t fr s urge y, Subcommitt ee SC 4,

B one a d joint r plac ement

This third edition canc ls an r plac s the se ond edition (ISO 14243- 2:2 0 ), of w hich it cons itut es a

minor r vision

ISO 14243 consis s of the folowing p rt , u de the g ene al title Impla ts fr s urge y — Wear o total

kne -oint pros theses:

— Part 1: L adin a d di s plac ement p ramete s fr wear-tes tin machines w ith lo d c ontrol a d

c or es po din env iro mental c onditions fr tes t

— Part 2 : Meth ds o meas ur ment

— Part 3 : L adin a d di s plac ement p ramete s fr wear-tes tin machines w ith di s plac ement c ontrol a d

c or es po din env iro mental c onditions fr tes t

The folowing p rt ar u de pr p ration

— Part 5: L adin a d di s plac ement p ramete s fr tes tin machines a d c orres po din enviro mental

c onditio s when tes tin dura i t y pe frma c e o the p teloemoral joint

Implants for sur g ery — Wear oftotal knee-joint

Part 2:

This p rt of ISO 14243 spe if ies a method of as es ment of wear of the tibial comp nent of t otal kne

-joint pros heses using the gra imetric t ech iq e for comp nent t est ed in ac ordanc with ISO 14243-1

or ISO 14243-3 asa pro riat e

2 Normati ve r eferences

The folowing document , in w hole or in p rt, ar normatively r fe enc d in this document an ar

in ispensa le for it a pl cation F or dat ed r fe enc s, only the edition cit ed a pl es F or u dat ed

r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment )a pl es

ISO 14243-1, Impla ts fr s urger y — Wear o total knee -joint pros thes es — Part 1: L adin a d

di s plac ement p ramete s fr wear-tes tin machines w ith lo d c ontrol a d c or es po din env iro mental

c onditio s fr tes t

ISO 14243-3, Impla ts fr s urge y — Wear o total knee -joint pros theses — Part 3 : L adin a d

di s placement p ramete s fr wear-tes tin machines w ith di s plac ement c ontrol a d c or es po din

env iro mental c onditio s f r tes t

3 Terms and definitions

F or the purposes of this document, the folowing t ermsand definitions a ply

3.1

we r

mat erial los from comp nent of the pros hetic joint d e t o combined mo ement an lo ding

4 Gravimetric method

4.1 Principle

The t es spe imen is so ked in a lubricant It is r peat edly r mo ed from the lubricant, cleaned,

dried an weighed u ti a st eady rat e of fluid sorption is es a l shed The t es spe imen is as es ed

subseq ently for wear b t es ing for los in mas in a kne -joint simulat or A lo ded or u lo ded,

non-articulating control spe imen subme g ed in the same lubricating fluid medium is int en ed t o alow for

fluid sorption an u de g oesthe same proc d r for r fe enc purposes

4.2 Reag ents and materials

4.2.1 Fluid test medium, in ac ordanc w ith ISO 14243-1 or ISO 14243-3 as a pr opriate

4.2.2 Propan-2-ol

4.3 A pparatus

4.3.1 Balanc e, with an ac uracy of ± ,1 mg , of suficient ca acity for the mas of the tes spe imen

4.3.2 Ultrasonic cle ner

4.3.3 Vacuum dr ying system, ca a le of achieving a v cu m of at leas 1 ,3 Pa (10 mi iTor )

4.3.4 Fitered inert-gas jet, e.g nitr og en

4.4 Test and c ontr ol specimens

4.4.1 Test specimen, conforming to ISO 14243-1 or ISO 14243-3 as a propriate

4.4.2 C ntr ol specimen, conforming to ISO 14243-1 or ISO 14243-3 as a pr opriate

4.5 Preparation of test and c ontr ol specimens for g ravimetric measur ements (pre-soak

c onditioning )

4.5.1 So k thetes spe imen an contr ol spe imen in the fluid tes medium (4.2.1) for 48 h ±4 h

4.5.2 Remo e the tes spe imen and contr ol spe imen from the fluid tes medium (4.2.1) an clean in

the ultr asonic cleane (4.3.2)

A ty ical cleaning r gime in the ultrasonic cleane is as folow s:

a) vibrat e for 1 min in deioniz d wat er;

b) rinse in deioniz d wat er;

c) vibrat e for 1 min in a mixtur of ultrasonic cleaning det erg ent at the conc ntration r commen ed

b the det erg ent man factur r;

d) rinse in deioniz d wat er;

e) vibrat e for 1 min in deioniz d wat er;

f) rinse in deioniz d wat er;

g) vibrat e for 3min in deioniz d wat er;

h) rinse in deioniz d wat er;

i) dry in a v cu m drying chambe (4.3.3)

Car should be taken t o a oid a rasion in the ultrasonic cleane w hich could lead t o a chang e in mas

4.5.3 Dry the tes spe imen an contr ol spe imen w ith a jet of fiter ed ine t gas (4.3.4)

4.5.4 So k thetes spe imen an contr ol spe imen in pr op n-2-ol (4.2.3) for 5 min ± 1 s

r eading s in r otation u ti at leas two r eading spe spe imen ag r ee within 0,1 mg Store the tes spe imen

and contr ol spe imen in a sealed d st-fr ee containe betwe n weighing s

4.5.7 Repeat 4.5.2 to 4.5.6 at inte v ls u ti the incremental mas chang e of the spe imen o e 24 h is

les than 1 % of thepr evious cumulative mas chang e

4.5.8 Re ord the a ver ag e incr ease in mas S of the contr ol spe imen

4.5.9 Take photog raphic r ecor ds of al the articulation an fixation surfac s of the spe imen Mar k the

tes sample with r eferenc p int so that afe the wear tes the location of the worn surfac s can be

identified r elative to the a esof the tes sample

4.6 Proc edure for g ravimetr ic me surement

4.6.1 Mou t the tes spe imens in the tes ing machine an con uct the wear tes in ac ordanc with

ISO 14243-1or ISO 14243-3as a propriate

4.6.2 Re ord the mas of the spe imens

4.6.3 On each oc asion when the tes spe imen and contr ol spe imen ar e r emo ed fr om the

wear-testing machine, r epeat the pr oc d res in 4.5.2to 4.5.6, 4.6.1 an 4.6.2

4.6.4 C lculate the g ra vimetric wear as show n in For mula (1):

W

n

=W

a

+ S

n

(1)

w he e

W

n

is the net mas los aft er n cycles of lo ding;

W

a

is the a e ag e u cor e t ed mas los ;

S

n

is the a e ag e inc ease in mas of the control spe imen o e the samepe iod

4.6.5 C lculate the a verag e wear rate a using F rmula (2) for the leas -sq ar es lnear fit r elationship

betwe n W

n

an the numbe of lo ding cycles n:

W

n

w he e W

n

is the net los in mas aft er n cycles and b is a cons ant

The z ro time point hal not be used in this calculation

4.6.6 Take photog r aphic r ecor ds of the articulating an fixation surfac s

5 Test r eport

The t es r p rt hal inclu e the fol owing information:

a) a r fe enc t o this p rt of ISO 14243, i.e ISO 14243- 2,

b) theidentity of the t es spe imens, as s at ed b the p rty submit ing the spe imen for t est ;

c) themethod of wear measur ment ( i.e gra imetric);

d) thev lueW

n for each measur ment using the gra imetric method;

e) the wear rat e, a ;

f) a r fe enc t o the wear t es method used from ISO 14243-1 or ISO 14243-3 as a pro riat e;

g) phot ogra hic r cords